Getting your message heard

In an increasingly challenging environment surrounding patient enrolment for clinical trials, the role of the communicator has never been more important

Patient recruitment to clinical trials has never been more challenging. With more than 80 per cent of clinical trials not recruiting to time (The McKinsey Quarterly: A cure for clinical trials, 2002, Rowe J et al) it is clear that more needs to be done if new medicines are to be brought to market in the most time and cost-efficient manner.

One area often overlooked during clinical development is the importance of evidence-based patient recruitment programmes. Too often, unengaging, poorly constructed and badly targeted communication is used to support patient enrolment to clinical trials.

Not only can evidence-based communication raise awareness of a particular clinical trial among potential participants and referrers, but effective communication is critical in supporting informed decision making among all those associated with a particular study.

The evidence speaks for itself. Recent studies found that only three per cent of US cancer patients were involved in clinical trials (US National Cancer Institute) and 40 per cent were unaware that clinical trial participation was a potential option open to them (Harris Interactive Publication. Healthcare News, 2005:5). However, 77 per cent of patients would consider clinical trial participation if it had been discussed with them.

These findings should be of concern to everyone as US cancer patients are arguably one of the most informed groups of patients and many oncologists consider the potential for clinical trial participation as part of the standard of care in oncology.

If it is bad in oncology, it is likely to be far worse in many other therapy areas. A focus on the importance of evidence-based communication in clinical trial recruitment is therefore long overdue.

The role of communicatorsThe role of communicators in supporting clinical trials is usually restricted to communicating key study milestones and study outcomes through the media.

However, communicators – with their expertise in engaging disparate stakeholders – can add significantly more value to a company's clinical development programme. Whether supporting the development of engaging patient materials, educating appropriate patient advocacy groups, motivating potential referrers or building longer-term partnerships so critical for future market access success, communicators can offer so much more than just study-related media relations.

Indeed, beyond raising awareness of a particular study, and with the advent of ever more complex clinical trials in harder-to-reach patient populations, superior communication is arguably fundamental to study enrolment success. In addition, effective communication is critical in supporting informed decision making among all study stakeholders. An informed study team is a motivated team, an informed referrer is a proactive one, an informed patient is one that can give his/her consent to study participation and an informed advocacy sector is better placed to support those who may turn to them for guidance.

However, support for informed decision making is so much more than a discussion and the provision of a range of materials. Highly effective clinical trial recruitment programmes necessitate an evidence-based and systematic approach to developing and disseminating messages and materials to ensure that the right study stakeholders get the right information, at the right time and in the right format.

Some of the key steps to building an evidence-based communication programme that supports patients in their informed decision making about potential clinical trial participation are considered below. The principles behind this approach apply equally to referrer and study-site outreach activities.

Step 1. Understand the study protocol and the potential challenges:What are the particular study protocol challenges that will require superior communication if patients are to be fully supported in their informed decision making? For example, this includes high frequency of visits, invasive procedures, study duration and the potential for receiving a placebo.

Step 2. Understand the drivers of participation:How do patients feel about clinical trials and why might they consider getting involved in a study? For example, this includes potentially gaining access to a medicine being investigated for a particular condition, advancing the understanding of a particular disease or doing something to help others like them.

Step 3. Understand the patient demographics, attitudes and behaviours:How many potential participants are there? How are they currently managed? What do they think about their disease and its treatment? Where do they get their information and support from? For example, while women diagnosed with breast cancer are undoubtedly some of the most pro-active information seekers on their condition with a very well-established support network, men diagnosed with lung cancer often rely solely on their doctors for information.

Step 4. Understand how patients absorb and assimilate information:The process of informed consent, where a patient discusses and considers the study protocol with the investigator before signing the study informed consent form is the most important stage in a patient's enrolment to a study. However, just because a patient listens to what the investigator tells them and reads the study materials he/she is given, it does not necessarily mean that he/she fully understands what they are committing to. Understanding how a patient absorbs information and reflecting this in communication about the study and his/her participation can support all those involved in the study.

Step 5. Develop, test and validate the messages and study identity:From the research undertaken, what are the messages that most effectively support a patient's informed decision making and how can these be presented in the most appropriate manner? For example, patients considering participation in a MS study might benefit from motivating materials in a larger font size, while some patients with mental health conditions may need simpler information, and materials that support their caregivers.

Step 6. Develop the patient enrolment programme:Only when the messages and study identity have been fully tested with patients, should the materials and support items be developed. Once completed, these will be ready for legal and regulatory approval and subsequent approval by national and local regulatory authorities as required.

Step 7. Launch the patient enrolment campaign to study sites:The launch of an evidence-based patient enrolment programme to the study sites that will use most of the outputs, either directly or indirectly, through outreach to referrers, patient advocacy groups and the media, can be highly motivational. In addition to supporting their patient enrolment efforts, a well-executed launch can demonstrate a sponsor's commitment to partnering with sites to deliver patient recruitment success.

Bulding partnerships beyond clinical trialsCommunicators can play a critical role in building longer-term study stakeholder partnerships beyond the traditional sponsor relationship. Establishing stakeholder partnerships early in clinical development not only enhances the success of a study, but it can help create the foundation for future market access success.

In building these partnerships, there is a number of key steps communicators should consider:

Step 1. Appreciate the longer-term market access strategy:Understanding what needs to be achieved following completion of a study will help identify potential partners who share the study sponsor's longer-term objectives for an investigational medicine. Liaising with market access colleagues is an important step in characterising these.

Step 2. Understand potential partners' needs:Whether it is a lead investigator, investigator, pro-active referrer or patient advocacy group, appreciating their needs enables a sponsor to offer support and services that add real value to potential partners' work. The research undertaken in support of a patient recruitment programme can identify additional activities and programmes of high value to study stakeholders.

Step 3. Thinking in the longer term:Too often, many good partnerships are lost following the completion of a particular study as everyone moves on to their next studies. As communicators are the guardians of many pre- and post-marketing authorisation relationships, they are well placed to bridge the relationship gap. However, it is important to remember that at all times total transparency is key. Openness and honesty are essential for any partnership, as is adherence to internal and external regulations and guidance.

Delivering a return on investmentBuilding on the investment in study stakeholders is just one of the ways that communicators can help maximise a company's return on investment from patient recruitment activities.

Communicators are well placed to use the insights gained in developing an evidence- based patient enrolment programme, as well as the outputs themselves. Let us consider for example, a study patient leaflet on the background to the condition that is being investigated. In addition to meeting the specific information needs of patients, the leaflet will have undergone internal legal and regulatory review and then have been approved for use by arguably the more stringent external regulatory bodies. Too often these types of materials are then shelved upon study completion. Smart communicators will retrieve these materials for repurposing at a later stage in a medicine's commercialisation.

Where to next?Currently communicators focus most of their efforts on a treatment during the pre-launch and post-launch periods. However, earlier application of communicators' skills can support a study recruit to time, while the relationships and materials developed in support of a study can add real value to a medicine's longer-term market access success. So why are more companies not adopting this approach? Ironically because communicators have not effectively communicated the added value they can bring.